510(k) K080197 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
| Applicant | Plasma Surgical, Ltd., Theale, Berkshire, GB |
| Decision | Substantially Equivalent, Jun 24, 2008 |
| Received | Jan 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2012 | Plasma Surgical Inc. PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System)
The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open sur Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.